Maternal Antibody in Milk After Vaccination

Brief Title

Maternal Antibody in Milk After Vaccination

Official Title

Maternal Antibody in Milk After Vaccination

Brief Summary

      Single-centre observational pilot study exploring pertussis specific antibody concentration
      in the breastmilk of women vaccinated against pertussis in pregnancy at different gestational
      ages. This study is made up of two stages: first stage to confirm recruitment methods and
      optimise the laboratory assay and a second stage to complete recruitment for the pilot study.
    

Detailed Description

      Pertussis disease is a highly infectious respiratory illness caused by Bordetella pertussis,
      which can cause significant morbidity and mortality. There has been an increase in cases in
      many high income countries with high vaccination coverage and in an attempt to control this,
      antenatal vaccination programmes have been introduced in several countries, including the UK.
      Vaccination in pregnancy is a strategy which seeks to boost the maternal antibody levels,
      increase the placental transfer of antibody and consequently increase the antibody levels in
      the infant.

      Human breast milk is a dynamic source of nutrition for the infant and is made up of many
      immunologically active components including antibody. The principal antibody in breastmilk is
      IgA and it has been shown that the amount of disease specific antibody in breastmilk can be
      increased by vaccination in pregnancy for a number of pathogens including pertussis.
      Secretory IgA (sIgA) plays an important role in immune exclusion in which it blocks adhesion
      of a pathogen onto a mucosal surface. As the first step of pertussis pathogenesis is the
      adhesion of bacteria to the ciliated respiratory epithelium in the nasopharynx and trachea
      there is a clear biological rationale for the hypothesis that receiving breast milk
      containing more IgA could enhance neonatal immunity and consequently the protective effects
      of vaccination in pregnancy.

      The best time in pregnancy for administering the pertussis vaccination is debated in the
      literature, with some advocating vaccination in the second trimester and others supporting
      later vaccination to coincide the time of serum antibody peak with optimum placental
      transfer. This issue has been considered exclusively from the perspective of serum
      immunoglobulin G (IgG), but the impact of timing of vaccination in pregnancy on IgA levels in
      milk may also be important. Previous studies have shown that there is a peak in the pertussis
      specific IgA in breast milk at day 10 following vaccination, which then declines, and
      consequently there may be a significant difference in the amount of IgA available in the
      breastmilk for an infant born to a mother vaccinated at 20 weeks for example, compared to a
      mother vaccinated at 32 weeks. This may therefore have an impact on future guidelines on
      optimal time of vaccination in pregnancy.
    

Study Type

Observational

Primary Outcome

Anti PT IgA at less than 48 hours in colostrum

Secondary Outcome

 Total IgA and IgG in colostrum and breastmilk

Condition

Pertussis

Intervention

Boostrix-IPV

Study Arms / Comparison Groups

 Women vaccinated at less than 24 weeks

Description:  Women receiving a pertussis containing vaccine at less than 24 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

50

Start Date

August 7, 2018

Completion Date

October 31, 2019

Primary Completion Date

August 31, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Singleton pregnancy

          -  Received pertussis vaccination between 16 and 32 gestational weeks

          -  Planning to breastfeed

        Exclusion Criteria:

          -  Received vaccination outside of the 16-32 week window

          -  Not planning to breastfeed

          -  Diagnosis of an immunodeficiency syndrome

          -  Multiple pregnancy
      

Gender

Female

Ages

18 Years - N/A

Contacts

Kirsty Le Doare, 02087253887, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

NCT ID

NCT03982732

Organization ID

18.0068

Responsible Party

Sponsor

Study Sponsor

St George's, University of London

Collaborators

 European Society for Paediatric Infectious Diseases

Study Sponsor

Kirsty Le Doare, Study Director, St George's, Univeristy of London

Verification Date

June 2019